Dockets Entered on January 17, 2007

Dockets Management



Dockets Entered On January 17, 2007



Docket #	Title

1999P-1340	Declared Eternity eau de Parfum Misbranded

1999P-1589	Stay effective date of approval for NDA 20-932 Roxicodone

1999P-2630	Establish a Daily Value for "added sugars"

2001P-0345	Listing the color additive yellow #5 for use in food/Drug

2002P-0317	Recall Aspartame as a Neurotoxic Drug

2003N-0076	Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements

2003N-0573	Draft Animal Cloning Risk Assessment

2005N-0403	Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs

2005P-0121	Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II

2006D-0383	Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases

2006D-0514	Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies

2006FL-0510	Food Allergen Notification (FAN): Imedeen Oral Beauty Products containing deep sea fish extract

2006N-0036	Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur


2006N-0493	International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization Scheduling Recommendations for Dronabinol (INN) and its Stereoisome


2006P-0415	Petition Seeking Regulation of Cloned Animals

1999P-1340	Declared Eternity eau de Parfum Misbranded

EMC 666	L. Detlor	Vol #:	24

EMC 667	Protect All Children's Environment	Vol #:	24

1999P-1589	Stay effective date of approval for NDA 20-932 Roxicodone

SUP 3	Kleinfeld, Kaplan & Becker, L. L. P.	Vol #:	2

1999P-2630	Establish a Daily Value for "added sugars"

EMC 809	A.	Vol #:	33

2001P-0345	Listing the color additive yellow #5 for use in food/Drug

EMC 1336	T. Donaldson	Vol #:	6

2002P-0317	Recall Aspartame as a Neurotoxic Drug

EMC 754	R. Blaylock	Vol #:	10

2003N-0076	Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements

EMC 1426	A. Griffin	Vol #:	12

EMC 1427	T. Hewitt	Vol #:	12

EMC 1428	M.	Vol #:	12

2003N-0573	Draft Animal Cloning Risk Assessment



EMC 47	D. Severini	Vol #:	5

EMC 48	N. Holton	Vol #:	5

EMC 49	D. Connell	Vol #:	5

EMC 50	T. Acock	Vol #:	5

EMC 51	P. Simon & G. Shakti	Vol #:	5

EMC 52	M. Rizzo	Vol #:	5

EMC 53	B. & N. DeCleene	Vol #:	5

EMC 54	D. Spruance	Vol #:	5

EMC 55	D. Shaw	Vol #:	5

SUP 1	FDA/CVM	Vol #:	16

2005N-0403	Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs



WDL 1	NDC Working Group	Vol #:	3

2005P-0121	Non-invasive Bone Growth Stimulator be reclassified from Class III to Class II

BKG 1	Background Material	Vol #:	8

N 1	FDA	Vol #:	7

2006D-0383	Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases



C 900	K. Krause	Vol #:	38

C 901	Illigible	Vol #:	38

C 902	J. Small	Vol #:	38

C 903	Illigible	Vol #:	38

C 904	T. Hurley	Vol #:	38

C 905	H. Arata	Vol #:	38

C 906	M. Husmann	Vol #:	38

C 907	G. Veira	Vol #:	38

C 908	M. Bergardy	Vol #:	38

C 909	P. Hurley	Vol #:	38

C 910	C. Taylor	Vol #:	38

C 911	R. Bemauls	Vol #:	38

C 912	G. Spitze	Vol #:	38

C 913	D. Haccoretta	Vol #:	38

C 914	M. Desotell	Vol #:	38

C 915	D. Agostine	Vol #:	38

C 916	M. Balic	Vol #:	38



C 917	A. Rousseau	Vol #:	38

C 918	P. Williams	Vol #:	39

C 919	M. Little	Vol #:	39

C 920	A. Drost	Vol #:	39

C 921	J. McCarty	Vol #:	39

C 922	M. Houlihan	Vol #:	39

C 923	J. Winter	Vol #:	39

C 924	M. Tritz	Vol #:	39

C 925	I. Wagner	Vol #:	39

C 926	K. Park	Vol #:	39

C 927	B. Bibb	Vol #:	39

C 928	C. Wilberding	Vol #:	39

C 929	B and K Cunningham	Vol #:	39

C 930	Illigible	Vol #:	39

C 931	Illigible	Vol #:	39

C 932	Illigible	Vol #:	39

C 933	M Harmon	Vol #:	39

C 934	M. Wirth	Vol #:	39

C 935	D and K Banwarth	Vol #:	39

C 936	131 signatures	Vol #:	39

C 937	M. Brunyansky	Vol #:	39

C 938	5 signatures	Vol #:	39

C 939	A Mimbrey	Vol #:	39

C 940	G. McDonald	Vol #:	39

C 941	B. Sherman	Vol #:	39

C 942	J and M Menetrey	Vol #:	39

C 943	Merck & Co., Inc. (Merck)	Vol #:	39

C 944	D and W Gruggs	Vol #:	39

C 945	T. Jivanjee	Vol #:	39

C 946	J. Minges	Vol #:	39

C 947	K. Gorkiewrcz	Vol #:	39

C 948	R and M Orbeck	Vol #:	39

C 949	M. LaLonde	Vol #:	39

C 950	J. Egar	Vol #:	39

C 951	B. Berg	Vol #:	39

C 952	4 signatures	Vol #:	39

C 953	L. Ries	Vol #:	39



C 954	E. Hruska	Vol #:	39

C 955	4 signatures	Vol #:	39

C 956	D. Bailey	Vol #:	39

C 957	P. Chapello	Vol #:	39

C 958	J and T Carrigan	Vol #:	39

C 959	J. Pelc	Vol #:	39

C 960	A. Ostrowski	Vol #:	39

C 961	P. Mullin	Vol #:	39

C 962	B. Ehlers	Vol #:	39

C 963	M. Baumgartner	Vol #:	39

C 964	T. Panaccion	Vol #:	39

C 965	G. Buzanowicz	Vol #:	39

C 966	R. and E. Gaumond	Vol #:	39

C 967	M. Devine	Vol #:	39

C 968	I. Sienerson	Vol #:	39

C 969	E. Brooks	Vol #:	39

C 970	R. Everts	Vol #:	39

C 971	H. Berry	Vol #:	39

C 972	D. Grubbs	Vol #:	39

C 973	J. Cullen	Vol #:	39

C 974	J. Habisz	Vol #:	39

C 975	A. Burwinkel, MD	Vol #:	39

C 976	M. Burwinkel, MD	Vol #:	39

C 977	P. Byrne, M.D.	Vol #:	39

C 978	K. Crocco	Vol #:	39

C 979	J. Reynolds	Vol #:	39

C 980	W. Bogue	Vol #:	39

C 981	J. Jahn	Vol #:	39

C 982	M. Herold	Vol #:	39

C 983	S. Collins	Vol #:	39

C 984	M. Neumann	Vol #:	39

C 985	L and C Yeary	Vol #:	39

C 986	E. Blonski	Vol #:	39

C 987	D. Pascarella	Vol #:	39

C 988	S. Sanchez	Vol #:	39

C 989	R. Castilano	Vol #:	39

C 990	No signature	Vol #:	39



C 991	No signature	Vol #:	39

C 992	E. Perona	Vol #:	39

C 993	K. Germano	Vol #:	39

C 994	Human Life International	Vol #:	39

C 995	E. Zurowski	Vol #:	39

C 996	J. Hayes	Vol #:	39

C 997	F. Good	Vol #:	39

C 998	T. Walsh	Vol #:	39

C 999	P. McElhose	Vol #:	39

C 1000	R. Zimmer	Vol #:	39

C 1001	L. Poteet	Vol #:	39

C 1002	A. Purnill	Vol #:	39

C 1003	B and M Pauley	Vol #:	39

C 1004	G. Colau	Vol #:	39

C 1005	C. Clark	Vol #:	39

C 1006	J. Storey	Vol #:	39

C 1007	A. Kirchner	Vol #:	39

C 1008	D and A O'Connor	Vol #:	39

C 1009	G. Trevaskis	Vol #:	39

C 1010	L and F Schneider	Vol #:	39

C 1011	G. Lopes	Vol #:	39

C 1012	J and D Bibb	Vol #:	39

C 1013	E. and A, Pool	Vol #:	39

C 1014	J. Betlach	Vol #:	39

C 1015	D. Thimons	Vol #:	39

C 1016	A. Horabeck	Vol #:	40

C 1017	D. Wiesner	Vol #:	40

C 1018	E. Bauer	Vol #:	40

C 1019	C. Pawelski	Vol #:	40

C 1020	P. June, MD, FCP	Vol #:	40

C 1021	S. Finley	Vol #:	40

C 1022	J. Kucia	Vol #:	40

C 1023	Concerned Citizens for Life	Vol #:	40

C 1024	J. Tabin	Vol #:	40

C 1025	T. Koch	Vol #:	40

C 1026	E. Rome	Vol #:	40

C 1027	A. Glaser	Vol #:	40



C 1028	B. Ward	Vol #:	40

C 1029	P and L Rausch	Vol #:	40

C 1030	J. Fields	Vol #:	40

C 1031	D. Paige	Vol #:	40

C 1032	L. Ruff	Vol #:	40

C 1033	K. Steger	Vol #:	40

C 1034	J. Hrbain	Vol #:	40

C 1035	B. Nicholson	Vol #:	40

C 1036	J. Lukasok	Vol #:	40

C 1037	L. Clarke	Vol #:	40

C 1038	4 signature	Vol #:	40

C 1039	Illigible	Vol #:	40

C 1040	M. Zapf	Vol #:	40

C 1041	F. and K. Riedel	Vol #:	40

C 1042	J. Hart	Vol #:	40

C 1043	P. Tedesco et al.	Vol #:	40

C 1044	No signature	Vol #:	40

C 1045	C. Mackay	Vol #:	40

C 1046	No signature	Vol #:	40

C 1047	M. Houlihan	Vol #:	40

C 1048	D and D williams	Vol #:	40

C 1049	B. Bibb	Vol #:	40

C 1050	H. Conlan	Vol #:	40

C 1051	S. Dowling	Vol #:	40

C 1052	M. Desotell	Vol #:	40

C 1053	W. Raiser	Vol #:	40

C 1054	J. Ripplinger	Vol #:	40

C 1055	D. Otrhalik	Vol #:	40

C 1056	S. Krutz	Vol #:	40

C 1057	S. Krutz	Vol #:	40

C 1058	E nd D Chilton	Vol #:	40

C 1059	M Hennes	Vol #:	40

C 1060	L. Hoffman	Vol #:	40

C 1061	H. Florcik	Vol #:	40

C 1062	P. Greninger	Vol #:	40

C 1063	E. Ripplinger	Vol #:	40

C 1064	K. Denley	Vol #:	40



C 1065	M and P Casa	Vol #:	40

C 1066	J. Vetson	Vol #:	40

C 1067	I. Vetsch	Vol #:	40

C 1068	M. Gillian	Vol #:	40

C 1069	P. Wesolowski	Vol #:	40

C 1070	B. Konopa	Vol #:	40

C 1071	M. Caruso	Vol #:	40

C 1072	B. Mauch	Vol #:	40

C 1073	M. Schlautnon	Vol #:	40

C 1074	G. Lopes	Vol #:	40

C 1075	J. Ellingson	Vol #:	40

C 1076	R. Cacka	Vol #:	40

C 1077	J. Bobek	Vol #:	40

C 1078	R. Meyer et al	Vol #:	40

C 1079	W and J Meyer	Vol #:	40

C 1080	H. Vagley	Vol #:	40

C 1081	J. MaLeahy	Vol #:	40

C 1082	J. Hoffman	Vol #:	40

C 1083	M. Scherber	Vol #:	40

2006D-0514	Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies



NAD 1	FDA	Vol #:	7

REF 1	Reference	Vol #:	2

2006FL-0510	Food Allergen Notification (FAN): Imedeen Oral Beauty Products containing deep sea fish extract

FLN 1	Ferrosan A/S	Vol #:	1

2006N-0036	Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur



EMC 11	L. Gallegos	Vol #:	1

EMC 12	A. Shinder	Vol #:	1

EMC 13	C. Jordan	Vol #:	1

2006N-0493	International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization Scheduling Recommendations for Dronabinol (INN) and its Stereoisome



EC 2	Solvay Pharmaceuticals	Vol #:	1

2006P-0415	Petition Seeking Regulation of Cloned Animals



EMC 36	V. Bernard	Vol #:	5

EMC 37	D. Anderson & V. Bernard	Vol #:	5

Page created on January 18, 2007 kk

FDA/Dockets Management